5/30/2008 Austin, TX press release Introgen Therapeutics Inc. (www.introgen.com) Highlights: - First Phase III Gene Therapy Cancer Trial in the US to Successfully Meet Study Objectives - Primary and Secondary Efficacy Endpoints Successfully Met, Study Objective Achieved - p53 Predictive Biomarkers Demonstrate ADVEXIN and Methotrexate Efficacy in Different and Complementary Patients - Clinical Utility of ADVEXIN in Comparison to Methotrexate Demonstrated Introgen Therapeutics, Inc. today announced that ADVEXIN® (p53 tumor suppressor therapy) significantly increased survival in end-stage head and neck cancer patients with prospectively identified p53 favorable profiles (7.2 vs. 2.7 months; p<0.0001). In the intent-to-treat (ITT) population, including patients with p53 favorable and unfavorable p53 profiles, ADVEXIN and methotrexate had similar overall survival while ADVEXIN had a superior safety profile. ADVEXIN is designed to restore p53 tumor suppression blocked in the majority of tumors. The compound works differently than other cancer therapies by restoring the effectiveness of p53 proteins to trigger natural tumor suppression mechanisms in cancer, without harming normal cells. “The increase in survival and tumor response, among the p53 favorable profile patients, highlights the value of developing ‘targeted’ therapy for patients with recurrent, refractory head and neck cancer,” said Jack A. Roth, MD, inventor of ADVEXIN and Professor and Bud Johnson Clinical Distinguished Chair, Department of Thoracic & Cardiovascular Surgery, Section Chief, Thoracic Molecular Oncology, and Director, W.M. Keck Cancer Center for Innovative Cancer Therapies, M.D. Anderson Cancer Center, Houston, TX. “ADVEXIN is an outstanding example of ‘targeted’ therapy” directed at a specific molecular abnormality in cancer [...]

5/28/2008 Ann Arbor, MI staff HemOncToday (www.hemonctoday.com) Induction chemotherapy as a selection method for concurrent chemoradiotherapy was found to be an effective treatment method for advanced oropharyngeal cancer, and better response to the treatment was associated with the presence of human papilloma virus. Previous research into the increasing incidence of oral/oropharyngeal tumors has indicated HPV as an etiologic factor. Although some reports suggest that HPV-positive individuals with these tumors have better outcomes, the reports have not been unanimous. Researchers at the University of Michigan Comprehensive Cancer Center in Ann Arbor tested the efficacy of induction chemotherapy followed by concurrent chemoradiotherapy or surgery/radiotherapy and assessed the effect of HPV on response and outcome. Study design The study included 66 patients (51 men) with stage III to IV squamous cell carcinoma of the oropharynx. Patients were treated with one cycle of cisplatin (100 mg/m2) or carboplatin (AUC 6) as well as 5-fluorouracil (1,000 mg/m2 per day for five days). This regimen was used as a selection method for those eligible for chemoradiotherapy: patients who achieved a greater than 50% response at the primary tumor received chemoradiotherapy. Patients with a complete histologic response were given adjuvant paclitaxel. Pretreatment biopsies of 42 patients were tested for high-risk HPV. Fifty-four of the 66 patients (81%) achieved the 50% response rate and 53 of these patients received chemoradiotherapy. Among those 53 patients, 49 (92%) achieved a complete histologic response with a 73.4% rate of organ preservation. The four-year overall survival rate was 70.4% with a disease-specific [...]

5/28/2008 Houston, TX staff newswise.com A gene therapy invented at The University of Texas M. D. Anderson Cancer Center is the first to succeed in a U.S. phase III clinical trial for cancer, as announced today at the American Society of Gene Therapy annual meeting in Boston. Introgen Therapeutics, Inc., reported results of its phase III trial of Advexin®, a modified adenovirus that expresses the tumor-suppressing gene p53, for end-stage head and neck cancer. "Cells become cancerous because p53 no longer functions. Restoring p53 works unlike any current cancer treatment because it treats the cancer genome," said Jack Roth, M.D., professor in M. D. Anderson's Department of Thoracic & Cardiovascular Surgery, who invented the drug and co-founded Introgen. He remains a shareholder and paid consultant to Introgen, and the University of Texas System is also a shareholder in Introgen. The p53 gene is inactivated in many types of cancer. Its normal role is to halt the division of a defective cell and then force the cell to kill itself. The trial showed that p53 expression in the patient's tumor before treatment is a reliable biomarker for how to treat head and neck cancer. Patients with a favorable p53 profile who received Advexin® had a median survival of 7.2 months, compared with 2.7 months for those whose tumor expressed high levels of mutant p53 before treatment. Patients with this unfavorable profile were better off taking the chemotherapy drug methotrexate, resulting in median survival of 5.9 months. "The important finding is that [...]

5/26/2008 Tokyo, Japan T Yoshida et al Diagn Ther Endosc, January 1, 1996; 3(1): 41-51 Photodynamic therapy (PDT) is a recently developed treatment involving the use of a photosensitizer and low power light, usually from a laser, to selectively destroy tumor cells. At present, we perform PDT for head and neck cancer using argon or excimer dye lasers with hematoporphyrin derivative as a photosensitizer. This study attempted to assess the utility and safety of PDT and to investigate the long-term outcome. All 24 patients had squamous cell carcinoma: 15 with laryngeal, 5 with lingual or oral, and 4 with pharyngeal cancer and were treated by PDT. Data were obtained from records from February 1988 through April 1995. After PDT, 12 of 15 laryngeal cancer patients were classified as having a complete remission (CR), as were 2 of the 5 lingual or oral and one of the 4 pharyngeal cancer patients. The patients were followed for 8 to 153 months. The longest duration of CR in patients treated by PDT alone was 148 months. Photosensitivity was experienced by all patients, but required no treatment. Liver, kidneys, and bone marrow showed no abnormal values. There were no clinically relevant adverse reactions, and patients with severe complications due to other types of treatment and elderly patients were also treated safely with this therapy. Authors: T Yoshida, H Kato, T Okunaka, T Saeki, S Ohashi, T Okudaira, AM Lee, H Yoshida, H Maruoka, H Ito, and S Funasaka Authors' affiliation: Department of Otolaryngology, Head [...]

5/26/2008 Omaha, NE WM Lydiatt et al. Arch Otolaryngol Head Neck Surg, May 1, 2008; 134(5): 528-35 Objective: To determine whether prophylactic treatment with the antidepressant citalopram hydrobromide, compared with placebo, could prevent major depressive disorder in patients undergoing therapy for head and neck cancer (HNC). Design: Prospective, randomized, placebo-controlled trial. Setting: Academic medical center. Patients: Thirty-six subjects were randomized, and 23 completed the study. Interventions: Subjects were randomized to receive 40 mg of citalopram hydrobromide or matching placebo (herein after, citalopram group and placebo group, respectively) for 12 weeks with a final visit at 16 weeks. Main Outcome Measures: The Hamilton Depression Rating Scale, psychiatric interview, and the University of Washington Quality of Life (UW-QOL) and Clinician Global Impression-Severity (CGI-S) scales. Results: The numbers of subjects who met predefined cutoff criteria for depression during the 12 weeks of active study were 5 of 10 (50%) taking placebo and 2 of 12 (17%) taking citalopram (Fisher exact test, P = .17). No patients in the citalopram group became suicidal, compared with 2 in the placebo group. Global mood state at the conclusion of the study as measured by the CGI-S scale was rated as at least mildly ill in 15% of those receiving citalopram compared with 60% in the placebo group (Fisher exact test, P = .04). Quality of life, measured by the UW-QOL, deteriorated in both groups from baseline but less so in the citalopram group. Conclusions: This study reports data from the first depression prevention trial in HNC [...]

5/26/2008 Aberdeen, Scotland staff The Press Association (ukpress.google.com) Scientists have discovered a link between mouth cancer and the genes which break down alcohol, it was revealed. A major international study found people's risk of developing oral cancer was related to genes which regulate how fast or slowly alcohol was metabolised by the body. Researchers at the University of Aberdeen spent five years studying hundreds of patients with cancers of the mouth, larynx and oesophagus at centres throughout Europe and Central and South America. They also studied patients who were free of the disease. The study focused on two genes involved in metabolising alcohol - a substance which is already known to be a risk factor for oral cancer. The academics found those with a variant in the genes appeared to be less susceptible to the cancers because alcohol was broken down more quickly. Dr Tatiana Macfarlane, senior lecturer at the University of Aberdeen's department of general practice and primary care, said: "The study showed that your risk of getting oral cancers is linked to genetics as well as lifestyle. "We found that, in particular, the risk depends on how fast your body metabolises alcohol. "The results suggest that the faster you metabolise it, the lower your risk. "These results provided the strongest evidence yet that alcohol consumption is strongly linked to oral cancers. The risk is particularly high if you also smoke or rarely eat fruit and vegetables."

5/25/2008 Omaha, NE Jenny Nowatzke KPTM Fox42 News (www.kptm.com) Patients with head or neck cancer only make up 2% of all cancer cases. But, a staggering 20% of those patients end up committing suicide. Now, a local doctor is determined to reduce that number all the way down to zero. "You just feel helpless and selfless and after awhile, you give up hope," said John Allbery. Five years ago, Allbery was faced with the fight of his life - throat cancer. He wasn't a smoker, so when he heard the doctor's words, he was speechless. "Naturally, I didn't believe it," he said. After undergoing radiation and chemotherapy, Dr. Bill Lydiatt with the Nebraska Medical Center asked Allbery to help him with a new clinical trial. Its goal - to reduce the risk of depression and suicide in head and neck cancer patients. "We tried to look at ways to intervene to make this a better outcome for them," Lydiatt said. He gave half the patients a placebo, and the other an antidepressant. After 12 weeks, he says the results were amazing. "The group that had the placebo had a fifty percent of depression, compared to fifteen percent in the treatment group," Lydiatt said. Allbery says, lucky for him, he was in the right group. "Thinking back now, now that I know I got the drug, I can't even imagine what it would have been like if I hadn't." With the success of the first trial, Lydiatt received a $1.6 million [...]

5/25/2008 web-based article staff Foresight Nanotech Institute (www.foresight.org) A nanotech approach to overcoming the resistance of some cancer cells to radiation therapy has been successfully tested in mice. From the National Cancer Institute’s Alliance for Nanotechnology in Cancer “Nanoparticle-Induced heating boosts antitumor radiation therapy“: Radiation therapy is a time-honored and effective component of modern cancer therapy, but its ultimate utility is limited by the fact that some cancer cells are resistant to ionizing radiation. Now, a research team led by Sunil Krishnan, M.D., of the University of Texas M.D. Anderson Cancer Center, has found that pretreating tumors with gold nanoparticles and near-infrared radiation dramatically improves the response of tumors to radiation therapy. Reporting its work in the journal Nano Letters [abstract], the Texas investigators showed that inducing a mild temperature rise in tumors increases blood flow throughout tumors, particularly in those regions of a tumor that are normally deprived of oxygen that results from the disrupted network of blood vessels found deep within tumors. To produce the mild temperature rise, or hyperthermia, the researchers used gold nanoparticles and infrared light. Gold nanoparticles become warm, or even hot, when irradiated with near-infrared light, an effect that other researchers are exploring as an anticancer therapy. In this study, the researchers chose to induce mild hyperthermia, which by itself will not kill tumor cells, using low-intensity infrared radiation. Although other studies had demonstrated convincingly that mild hyperthermia sensitizes tumors to radiation therapy, previous methods of raising the temperature of tumors have not proved [...]

5/24/2008 New York City, NY Tara Parker-Pope New York Times (nytimes.com) Hamilton Jordan, the former White House chief of staff for President Jimmy Carter, was a well-known force in the health community. During the past 24 years he battled four different forms of cancer and urged cancer patients to empower themselves with information. After bouts with non-Hodgkins lymphoma, prostate cancer and skin cancer, Mr. Jordan, 63, yesterday died as a result of mesothelioma, another form of cancer. Mr. Jordan often speculated that his lymphoma may have resulted from exposure to the chemical Agent Orange while serving as a volunteer during the Vietnam War. Mesothelioma also has been linked to the chemical. In his 2001 memoir, “No Such Thing as a Bad Day,'’ Mr. Jordan outlined his “Top 10 Tips for Cancer Patients.'’ He spoke about them during this undated interview with WebMD. Here they are: No. 1: Be an active partner in the medical decisions that are made about your life. Don’t be passive. Learn about your disease, and participate in the decisions that are made….For example with my lymphoma, if I would have accepted the first treatment offered, I’d be dead today. It was assumed that I only had a mass in my chest. I later learned that the lymphoma was all through my body. No. 2: Seek and know the truth about your illness, and prognosis. If you don’t have the facts, and don’t know the truth, you won’t make good decisions. It takes courage to ask questions [...]